HER2 양성 전이성 유방암 : 신규 요법, 미충족 수요 및 TPP 인사이트 리포트(2026년)

HER2-Positive Metastatic Breast Cancer Emerging Therapy and TPP Insights

Thelansis's "HER2-Positive Metastatic Breast Cancer Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

HER2-Positive Metastatic Breast Cancer Overview

HER2-positive metastatic breast cancer is a highly aggressive molecular subtype driven by amplification of the ERBB2 gene, resulting in overexpression of the human epidermal growth factor receptor 2 (HER2), a transmembrane tyrosine kinase. Historically associated with rapid disease progression, high visceral involvement, and a strong propensity for central nervous system (CNS) metastases, the disease course has been significantly transformed by targeted therapies.

Accurate determination of HER2 status via immunohistochemistry (IHC) or in situ hybridization (ISH) is essential for guiding treatment. The modern therapeutic paradigm is based on sequential HER2-targeted therapy, beginning with dual monoclonal antibody blockade using trastuzumab and pertuzumab in combination with chemotherapy.

Upon progression, treatment has evolved with the introduction of next-generation antibody-drug conjugates (ADCs), particularly trastuzumab deruxtecan (T-DXd), which has demonstrated superior efficacy and largely replaced earlier agents such as T-DM1. In later lines, especially for patients with brain metastases, CNS-penetrant tyrosine kinase inhibitors (e.g., tucatinib) play a critical role in achieving both systemic and intracranial disease control.

Key Highlights

• HER2+ mBC is a highly aggressive but targetable cancer subtype with strong dependence on biomarker-driven therapy
• UK prevalent cases expected to grow from ~12.5K to ~15.9K (~2.4% CAGR)

Market Overview

• UK market projected to grow from ~$180M to ~$340M (~6-7% CAGR)
• Growth driven by next-generation ADCs and targeted therapies, with continued innovation in later-line settings

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

Companies Mentioned

• Ambrx, Inc.
• Criterium, Inc.
• Jazz Pharmaceuticals
• AstraZeneca
• Affibody
• Beijing Biotech
• Jiangsu HengRui Medicine Co., Ltd.
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Nanjing Chia-tai Tianqing Pharmaceutical

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)